Regulatory Affairs Associate Manager GCC📣 Job Ad

About the Role

Sobi - Swedish Orphan Biovitrum AB is seeking a Regulatory Affairs Associate Manager GCC to manage regulatory activities across the Gulf Cooperation Council (GCC) region. This full-time position requires 5-10 years of experience in pharmaceutical regulatory affairs within GCC markets.

Role Overview

The Regulatory Affairs Associate Manager GCC is responsible for overseeing regulatory operations in Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain. The primary objective is to ensure timely product registrations, maintain product lifecycles, and adhere to local health authority requirements. This role supports regional business objectives through effective regulatory planning, submission management, and collaboration with internal teams and external agents.

Key Responsibilities

• Manage regulatory activities for new registrations, renewals, variations, and other post-approval submissions across GCC markets.
• Develop and execute regulatory submission plans aligned with business priorities and product launch timelines.
• Coordinate the preparation, review, dispatch, and submission of regulatory dossiers in CTD/eCTD or country-specific formats.
• Lead end-to-end submission activities and follow up with health authorities via local agents to ensure timely approvals.
• Act as the primary regulatory contact for local agents and support communications with health authorities.
• Coordinate responses to health authority queries, deficiency letters, and regulatory commitments with relevant internal functions.
• Monitor and communicate new regulatory requirements and assess their impact on ongoing and planned submissions.
• Collaborate with Global/Regional Regulatory Affairs, Medical, PV, Quality, Supply Chain, Commercial, Finance, and Labelling teams to support product registration and lifecycle activities.
• Support the implementation and maintenance of local product information and labelling in compliance with local requirements.
• Prepare regulatory status updates, presentations, and reports for internal stakeholders and management.
• Lead or support additional RA projects and initiatives as assigned.

Qualifications and Requirements

• Bachelor’s degree in Pharmacy, Life Sciences, or a related scientific field.
• 5–7 years of experience in pharmaceutical regulatory affairs within GCC markets.
• Strong knowledge of regulatory requirements and submission processes in Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain.
• Experience in managing product registrations and lifecycle activities for innovative and/or specialty products is preferred.
• Fluency in English and Arabic.

Required Skills

• Strong organizational, communication, and project management skills.
• Ability to manage multiple priorities and work effectively with cross-functional teams.